A Risorine study in sputum positive patients after 8 weeks of conventional treatment
Phase 4
Completed
- Conditions
- Health Condition 1: A150- Tuberculosis of lung
- Registration Number
- CTRI/2012/11/003096
- Lead Sponsor
- CADILA PHARMACEUTICALS LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
•Males/females in the age range of 18-60 years
•Category-I sputum positive pulmonary tuberculosis patients who remain sputum positive at the end of 8 weeks of conventional intensive phase therapy
•Compliance to treatment
•Willing to give informed consent
Exclusion Criteria
•Sputum negative patients
•Pregnant or lactating females or females on oral contraceptives
•HIV positive status
•Seriously ill and moribund patients
•Hypersensitivity to any of the drugs to be administered as part of regimen
•Treatment noncompliant patients as per treating physician discretion
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate effect of one monthâ??s Risorine therapy on plasma rifampicin levels in Category-I sputum positive pulmonary tuberculosis patients who remain sputum positive at the end of 8 weeks of conventional intensive phase therapy (Rifampicin 450mg + Isoniazid 300mg + Ethambutol 800mg + Pyrazinamide 1500 mg, all given once daily).Timepoint: 30 days from randomization
- Secondary Outcome Measures
Name Time Method ATimepoint: NA